FDA Approves Brain Test for ADHD
The U.S. Food and Drug Administration on Monday approved the first brain test that could help doctors diagnose attention-deficit hyperactivity disorder (ADHD) using biological evidence, and not just the results of psychiatric evaluations.
The device, called the NEBA System, is a 20-minute test that uses an electroencephalogram (EEG) test to look at a patient's brain waves. Specifically, it measures the ratio between beta and theta brain wave frequencies, which studies have shown is higher in children and teens with ADHD.
"Diagnosing ADHD is a multi-step process based on a complete medical and psychiatric exam," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in an agency statement. "The NEBA System, along with other clinical information, may help health care providers more accurately determine if ADHD is the cause of a behavioral problem."
The test is already used to assess sleep issues, measure unconsciousness, diagnose side effects from head injuries and monitor the brain during surgery, according to CBS News.
A company-funded study of almost 300 children and teens with behavior problems showed that the test, when coupled with standard diagnostic criteria, helped physicians more accurately diagnose ADHD than a doctor's exam alone.
ADHD affects nearly 7 percent of children between the ages of 3 and 17, and a recent government report found that 11 percent of all school-aged children have been diagnosed with the disorder, the FDA statement said.